PrEP'ing: Are You Ready? Doctors and Advocates Are Gearing Up to Bring Truvada PrEP to People at Greatest Risk of Infection

Risk Perception

Realizing that you may be at risk, however, is one of the hurdles for PrEP usage. Surveys of people at high risk of becoming HIV-positive have repeatedly found that many report they were at low or no risk of infection, but after testing, many were in fact already positive.

This was raised as one of the possible reasons for the disappointing results of Truvada PrEP in women in the FEM-PrEP study. The women who became infected (an equal number in both the placebo -- fake pill -- and Truvada groups) had indicated that they were at low risk for acquiring HIV.

Did the women given Truvada not take it because of that belief? Their blood work showed little or no evidence of the drug being in their system. Largely thanks to PrEP research, "risk perception" is now an important consideration in prevention.

Yet, the large Partners PrEP study showed that Truvada did protect women against HIV. So did a CDC study in Botswana.

All of which goes to show the potential value of PrEP. Undoubtedly, sex can be complicated, and as the stories above show, often easier done than said (or discussed).

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What You Don't Know

Ironically, Chris could have used another medication intervention that's long been available, called PEP, for post-exposure prophylaxis. If certain HIV medications are taken for 28 days, beginning within 72 hours after sexual exposure, they can prevent infection from taking place. It's something he didn't think about because he wasn't aware of it.

Researchers have written about the lack of awareness among gay men of the availability of both PEP and PrEP. When there is awareness, it sometimes goes along with misunderstanding or downright misinformation. Truvada is not, for example, a morning-after pill as some believe.

If Truvada is approved for use in HIV-negative individuals, the lack of awareness around its prevention power should change drastically, with education becoming possible by its manufacturer, clinics, and community organizations.

To Be Young

"We see PrEP for youth not as a lifelong medication but as a stopgap measure," said psychologist Sybil Hosek, Ph.D., of Stroger Hospital of Cook County, the Chicago site for the Adolescent Trials Network (ATN) for HIV/AIDS Interventions.

"We know that adolescence is a risky time," said Hosek. "There's a lot of impulsivity and a lot of behavior changes -- hormonal, psychological, and emotional -- that put people in vulnerable positions when it comes to HIV. And so we feel that PrEP may be a great option during that maturation period."

The ATN points to CDC statistics showing that among adolescents and young adults (ages 13 to 25), the estimated percentage of HIV infections resulting from male-to-male contact increased from 57% in 2005 to 68% in 2008, while infections resulting from heterosexual contact or injection drug use decreased. For black youth, however, the increase was 73% in that time period.

ATN's Project PrEPare has two studies looking at PrEP effectiveness now that its initial research has shown that youth would accept and use PrEP (feasibility).These two studies are scheduled to enroll 300 youth at the network's 14 sites across the country, including Chicago. Visit www.projectpare.net.

Like other PrEP research, Project PrEPare provides condoms and counseling along with medication.

As to the argument that money should be used for treatment of actual HIV infection rather than prevention, Hosek said they're both part of the same package, with PrEP expected to increase HIV testing levels and awareness of previously unknown infection with the need for access to treatment. Moreover, she said it would help providers talk to their patients about getting HIV-positive partners into care and treatment. Like many advocates, she also points to the fact that Truvada PrEP -- especially for short-term use -- costs less than a lifetime of HIV therapy.

"I think it would help people to remember their own youth," said Hosek. "It's a time of exploration. It's a time of emotional energy and risk taking, of cognitive development. Their brains are maturing. Pleasure often takes precedence over planning. Saying 'just use a condom' is not working.

"Not that condoms aren't a great option," she continued, "but some people just aren't going to use them. So I think the more options we have for youth, the better."

Turning the Tide

In February, Boston's Fenway Institute issued a 59-page report in which it stated that, based on initial study results, "PrEP could be the 'game changer' needed to more effectively fight HIV." The institute, one of two U.S. sites involved in iPrEx, urged the FDA to approve Truvada PrEP. It continues to conduct PrEP research through HPTN 069 (NEXT PrEP), and is also involved in HPTN 061 (the BROTHERS study), a multiple-component intervention for black MSM.

HPTN (HIV Prevention Trials Network) hailed the Truvada PrEP decision as "a milestone for HIV prevention" and a webinar announcement referred to PrEP as "a bridge to the end of AIDS."

With flat funding for the AIDS Drug Assistance Program and cuts to Medicaid that are becoming more common in the states, more and more people may find themselves without access to treatment, let alone prevention. There is free access to Truvada PrEP through the iPrEx study which has expanded (iPrEx OLE) with three U.S. sites (Chicago, Boston, and San Francisco). There may also be patient assistance or co-pay assistance programs available if PrEP is FDA approved.

Earlier, in August of 2011, six organizations from around the country devoted to HIV/AIDS work and services (the AIDS Foundation of Chicago, AVAC, the Black AIDS Institute, the National Minority AIDS Council, Project Inform, and the San Francisco AIDS Foundation) urged the Department of Health & Human Services (DHHS) to establish so-called "demonstration projects" to examine PrEP effectiveness out in the real world, especially among the hardest-hit MSM of color. A year later, few demonstration projects are underway.

San Francisco Joins Miami

San Francisco and Miami, two cities that have traditionally had some of the highest rates of HIV infection in the country, have teamed up for a PrEP demonstration project funded by the National Institutes of Health (NIH).

Stephanie Cohen, M.D., M.P.H., medical director of the City Clinic for sexually transmitted infections (STIs) for the San Francisco Department of Public Health, said individuals accessing care from the clinic who are at risk of HIV infection will be offered Truvada PrEP. In addition, the Magnet gay men's health clinic in the Castro will refer men to the program.

"We are looking at uptake in PrEP -- who's interested in it, who's not, and why," said Cohen. "We plan to develop marketing and education messages from what we learn in our, and other, demonstration projects."

The goal is to enroll 300 MSM in San Francisco and 200 in Miami. A demonstration project is also in the works for New York City, she said.

"Does it work? Yes, we know it does, but how do we get it out there?" said Cohen.

The California HIV/AIDS Research Program (CHRP) of the University of California is also conducting a PrEP demonstration project, in cities throughout the state (including Oakland, San Diego, and Long Beach), focusing on high-risk MSM of color "who lack resources for testing and counseling." The program will also look at the use of TLC+ (testing and linkage to care plus treatment) in men who become infected.

"It's an historic moment in HIV prevention," said Cohen, "and there's a lot of work to be done in learning how to use this new prevention tool."

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